Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life
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| ClinicalTrials.gov Identifier: NCT01030250 |
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Recruitment Status :
Active, not recruiting
First Posted : December 11, 2009
Last Update Posted : March 21, 2023
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| Condition or disease |
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| Breast Cancer |
60% of all cancers and 70% of cancer mortality occur in people greater than 65 years of age, defining cancer as a disease of older adults. Breast cancer is no exception to this rule where almost half of all new breast cancers in the United States are diagnosed in women 65 years of age or older1. Despite the association between cancer and aging, treatment recommendations and data acquired from prospective clinical trials in older women with breast cancer are sparse. As a result, physicians and older adults have limited data to guide treatment recommendation, make dose adjustments and manage toxicities in older adults. Aging is invariably associated with changes in physiology which can impact the pharmacokinetics and pharmacodynamics of cancer therapy. The potential for increased toxic effects in the older patient becomes an important concern. Therefore, it may not be reasonable to extrapolate data regarding toxicity from clinical trials, which primarily include younger, healthier patients. In addition, the age-related impact of adjuvant therapy on the functional status and quality of life of older versus younger adults has not been rigorously evaluated, and risk factors for toxicity, other than chronological age, need to be studied among older adults receiving anthracycline and non-anthracycline based chemotherapy regimens.
The goal of this study is to prospectively describe the longitudinal trajectory of functional status, comorbidity, and quality of life from before the initiation of chemotherapy to 6 months after the completion of treatment in older (65 and older) and younger (under 65) adults. We will determine the effect of pre-treatment physical functioning on physical recovery (ie, physical function at end of chemotherapy and 6 months later) after the course of adjuvant chemotherapy. In addition, we will explore if factors other than chronological age (functional status, comorbid medical conditions, nutritional status, psychological state, cognitive function, and social support) predict which patients are more likely to experience treatment morbidity (defined as grade 3-5 toxicity, hospitalization or urgent care visits, dose reduction or delay, or premature discontinuation of the planned chemotherapy course)
| Study Type : | Observational |
| Actual Enrollment : | 238 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Adjuvant Therapy in Older Versus Younger Women With Breast Cancer: Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life |
| Actual Study Start Date : | June 11, 2009 |
| Actual Primary Completion Date : | August 14, 2019 |
| Estimated Study Completion Date : | December 31, 2023 |
| Group/Cohort |
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Under 65 years
Breast cancer patients receiving adjuvant chemotherapy. Those under 65 years of age will be prospectively evaluated for outcome.
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Over 65 years
Breast cancer patients receiving adjuvant chemotherapy. Those over 65 years of age will be prospectively evaluated for outcome.
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- Describe longitudinal trajectory of physical functional status and quality of life and determine if the patient assessment measure predicts morbidity in adult breast cancer patients from prior to adjuvant chemotherapy to 6 months after end of treatment. [ Time Frame: 2 years ]
- Assess potential biomarkers for physiologic age, including Advanced Glycation Endproducts (AGEs) and markers for oxidative stress and inflammation (e.g. 8-OHdG). [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with stages I-III breast cancer receiving adjuvant chemotherapy
- Able to understand English
- Able to provide informed consent
- Patients of any age and performance status are eligible
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030250
| United States, California | |
| City of Hope | |
| Duarte, California, United States, 91010 | |
| Principal Investigator: | Arti Hurria, MD | City of Hope Medical Center |
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT01030250 |
| Other Study ID Numbers: |
08242 R03AG050931 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 11, 2009 Key Record Dates |
| Last Update Posted: | March 21, 2023 |
| Last Verified: | March 2022 |
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Breast Cancer Adjuvant Chemotherapy |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |